MAUDE Adverse Event Report: ABBOTT VASCULAR HT WHISPER GUIDE WIRES WITH HYDROPHILIC COATING

Catalog Number	1005359HJ
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	10/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001.The device was not returned for evaluation.The reported patient effect of perforation is listed in the hi-torque guide wires instructions for use as a known patient effect associated with use of this device.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as reportedly during one of the critical steps of wire manipulation and advancement of the sheath the patient coughed then turned their head resulting in the reported perforation.The treatment appears to be related to the operational context of the procedure as two 4.0x16mm graftmaster covered stents successfully sealed the perforation.There is no indication of a product quality issue with respect to manufacture, design or labeling.The three additional graftmaster devices referenced are being filed under a separate medwatch reports.
Event or Problem Description
It was reported that the procedure was performed to treat the right carotid artery which was reported to be severely narrowed at 75% or greater.A 7fr 90cm shuttle sheath which was placed in the proximal to mid-segment of the right common carotid artery.It should be noted that the patient was not cooperative and was constantly moving, talking, and coughing throughout the procedure.During one of the critical steps of wire manipulation and advancement of the sheath the patient cough then turned their head, which resulted in a perforation of the cavernous portion of the right internal carotid artery by a whisper guide wire.Following pre-dilatation, a 4.0x16mm graftmaster rx covered stent system was advanced but failed to cross due to the anatomy.The covered stent system was removed and re-advanced, but again failed to cross.A 7fr guideliner support catheter and an unspecified diagonal guide wire were advanced.The 4.0x16mm covered stent was deployed at 17 atmospheres (atms) for 30 seconds.Due to the perforation length, a second 4.0x16mm graftmaster rx covered stent system was advanced into the distal segment of the right internal carotid artery but just proximal to the origin of the ophthalmic artery and deployed at 18 atms for 12 seconds.The covered stent was post-dilated with a 5.0mm trek balloon to post dilate the proximal and distal edges of the covered stent.The distal edge of the covered stent landed just short of the distal edge of the perforation.An attempt to pass a 2.80x16mm graftmaster covered stent system was made but was not successful due to ever angulation and stiffness of the previously deployed covered stent.The deployed covered stent was post-dilated once more with a 5mm balloon up to two minutes at a time to seal the perforation.At that onset of this new neuro intervention the patient did complain of some headaches, but with deployment of the covered stents the patient¿s symptoms of headaches were resolved.The patient did not have any focal neurologic signs.With regards to the right internal carotid artery, it was successfully treated with multiple non-abbott stents.No additional information was provided.

• Brand Name: HT WHISPER GUIDE WIRES WITH HYDROPHILIC COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9306277
• Report Number: 2024168-2019-13442
• Device Sequence Number: 2172202
• Product Code: DQX
• UDI-Device Identifier: 08717648037832
• UDI-Public: 08717648037832
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 1005359HJ
• Device Lot Number: 9082971
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Weight: 68